Principal Statistical Programmer

Viiv Healthcare; Durham (NC); In loco; USD 140.000 - 180.000; Tempo pieno

Vantaggi offerti da questo lavoro

U.S. employee benefits as GSK employees

Descrizione del lavoro

GlaxoSmithKline is seeking a Senior Medical Director to lead programming for clinical studies aimed at advancing HIV research. The ideal candidate will have over 6 years of clinical programming experience in the pharmaceutical industry along with strong skills in R programming and experience using AI tools to enhance workflows.

This role involves collaborating cross-functionally, ensuring adherence to regulatory standards, and mentoring junior team members. A Bachelor's degree in Statistics or related fields is essential.

Competenze

• Experience in clinical programming for 6+ years.
• 5+ years in pharmaceutical or biotechnology industry.
• Expertise with generative AI tools.

Mansioni

• Lead programming for studies and ensure efficient development.
• Select tools and address technical challenges.
• Mentor junior programmers.

Conoscenze

R programming

Clinical programming

Data analysis

AI/ML tools

Formazione

Bachelor’s degree in Statistics, Computer Science, or a related field

Strumenti

GitHub Copilot

R

Python

Descrizione del lavoro

Overview

ViiV Healthcare is a global specialty HIV company wholly committed to researching and delivering new medicines for people living with–and at risk of–HIV. The Senior Medical Director, in partnership with the Principal Statistical Programmer, will play a pivotal role in advancing our mission to leave no patient behind by ensuring clinical excellence in early development programs (with a focus on long‑acting medicines) and providing medical governance for Phase1–4 studies while leading programming activities for one or more studies, ensuring high‑quality development, validation, and delivery of complex analysis outputs.

Responsibilities

• Lead programming for studies, ensuring efficient development and validation of analysis packages.
• Select appropriate tools/languages and solve complex technical challenges.
• Identify and implement improvements, including the use of AI/ML tools.
• Contribute to departmental initiatives and technical strategy.
• Ensure adherence to standards (e.g., GPP, CDISC) and regulatory requirements.
• Perform QC on critical outputs and technical documents (e.g., cSDRG, ADRG).
• Maintain governance and oversee TMF compliance.
• Drive adoption of modern technologies, standards, and Agile practices.
• Provide technical input on programming strategies and study design.
• Act as SME for emerging tools when needed.
• Communicate technical concepts, risks, and timelines clearly to stakeholders.
• Mentor junior programmers and share best practices internally and externally.
• Support sprint planning and project delivery across studies.
• Collaborate cross‑functionally and manage data access appropriately.
• Support regulatory interactions and contribute to CoE activities.
• Serve as Lead Programmer for complex or multiple studies.
• Ensure quality, compliance, and efficient execution of programming activities.
• Make data‑driven decisions and proactively address risks and issues.

Qualifications

Basic Qualification

• Bachelor’s degree in Statistics, Computer Science, or a related field.
• Expertise in R programming.
• 6+ years of clinical programming experience.
• 5+ years of experience in the pharmaceutical or biotechnology industry.
• Experience using generative AI tools and coding assistants (e.g., GitHub Copilot, Codex, and Claude) to improve programming efficiency, automation, code quality, and analytical workflows in clinical programming.

Preferred Qualification

• Strong experience supporting HIV clinical trials and drug development within the pharmaceutical or biotechnology industry.
• Advanced degree in Statistics, Computer Science, Data Science, or a related discipline.
• Experience using generative AI tools and coding assistants (e.g., GitHub Copilot, Claude, or Codex) to improve programming productivity and automation.
• Familiarity with modern software engineering practices, including Git‑based workflows, reusable frameworks, and automation pipelines.
• Experience with R, Python, and open‑source analytics tools within regulated clinical development environments.
• Experience contributing to standards development, process improvement, or digital transformation initiatives.
• Knowledge of Agile delivery methodologies and collaborative product development approaches.
• Demonstrated experience leading programming activities for complex clinical studies or multiple projects.
• Strong understanding of CDISC standards, regulatory expectations, and quality/compliance requirements.
• Excellent analytical, problem‑solving, communication, and stakeholder management skills.
• Experience mentoring or guiding junior team members.

Benefits

• U.S. employees receive the same benefits options and plans as GSK employees.

Equal Opportunity Employer

ViiV is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us [e-mail].